Kornimate/medical-research-clean huggingface dataset:
anxiety and fear of cancer before and after banding without resection in small set management (quali-banding-set)

Conditions: Gastrointestinal Subepithelial Tumors

Summary: to analyze the hypothetical improvement in anxiety degree, quality of life and fear of cancer in patients diagnosed with a small gastrointestinal subeptithelial tumor when opting for the removal of the lesion.

this "quality of life" study is directly related to the "banding-set" study (nct03247231), whose main aim is to analyze the effectiveness and safety of endoscopic band ligation without resection in the small gastrointestinal subepithelial tumours management. using three validated tests (hospital anxiety and depression scale \[hads\], cancer worry scale \[cws\] and european five-dimension quality of live test \[euroqol-5d\]) patients are evaluated before and after the endoscopic procedure. three main groups of patients are presented: * group a, in which the subephitelial tumour is successfully removed \[hypothesis: anxiety and fear of cancer should decrease\]. * group b, in which the subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...) \[hypothesis: anxiety and fear of cancer shuold be similar before-after\]. * group c, in which the subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients \[hypothesis: anxiety and fear of cancer should decrease\].

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years. * patient able to sign and understand the informed consent. * patient with a previously corroborated diagnosis of a subepithelial tumor (set) by previous endoscopic ultrasonography (eus), or possible diagnosis of set by finding a subepithelial lesion (sel) in a conventional endoscopy performed that will require a eus study. * acceptance by the patient as a candidate of the banding-set study (nct03247231) of assessment of the effectiveness and safety of band ligation without resection of subepithelial tumors of the digestive tract ≤15-mm, with the prior signing of the informed consent of this study. * patient that understand the concept of the study and will complete all the time frame until the study end exclusion criteria: * no informed consent. * no banding-set study (nct03247231) informed consent. * patients with functional diversity, unable to understand the nature and possible consequences of the study. * patients unable to maintain subsequent follow-up (lack of adherence). * patients with a life expectancy of less than 12 months.

Keywords: tumourophobia anxiety for cancer quality of life cancer worry scale (cws)
randomized trial on resin infiltration in deciduous teeth

Conditions: White Spot Lesions; Caries

Summary: it was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.

* to determine the number of patients, sample size was based on data from studies assessing fluoride varnish efficacy in children with deciduous teeth (progression of caries reduction by 33 %)(95% ci, from 19 to 48%, p\<0.0001); (α = 0.05; power = 80%; chi-square test2). the calculated sample size was 60 children and 120 white spot lesions. the initially planned number of participants was increased by expected 20% drop-out after 1 year, at least 72 children; the minimal number of treated active caries lesions amounted to 144. * participants were allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using package blockrand in r statistical software, sealed in envelopes. * the children were re-examined clinically by the same 2 examiners as at baseline evaluation. * statistical analyses were performed using statistical software statistica 10 (statsoft), the level of significance was set at 0.05. intra-examiner reliability was assessed by kappa statistics. * to compare average values between two independent groups u mann-whitney test was used (for e.g. to compare experimental group with the control one); wilcoxon signed-rank test was used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). comparison of fractions was conducted using pearson's chi-square test of independence and z test. the 95% confidence intervals were calculated on the basis of normal approximation.

Eligibility criteria:
inclusion criteria: * at least two active smooth-surface caries lesions in deciduous teeth (icdas ii code 2) * a written consent of parents/ guardians for participation in the research study exclusion criteria: * age above 5.9 years * systematic disease * cavitated lesions * enamel defects * current participation in another study * a planned change of residence within one year

Keywords: resin infiltration randomized clinical trial fluoride varnish caries lesion deciduous teeth
wound dressings adapted to wound exudate and bacterial load in therapy resistant large sized leg ulcers

Conditions: Varicose Ulcer

Summary: the purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze

background: moist wound therapy of venous leg ulcers is well established by both in vitro or animal studies and studies at ulcers smaller than 20 cm². mostly larger venous leg ulcers have a stronger exudation than smaller leg ulcers. therefore larger ulcers exhibit apparently moist conditions also beneath simple gauze, ointments and compresses. the purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze. patients and methods: in an open, non-randomized prospective trial 139 consecutive patients (86 female, 53 male) with long standing (159 ± 335 weeks) large sized (\> 20 cm², 53.8 ± 90.6 cm²) venous ulcers were included. the pre-treatment with compresses, ointments and gauze and two layer short stretch bandages during the time before consulting our wound outpatient department was compared to the following therapy protocol: after two weeks with four layer bandages compression stockings were applied. after a surgical debridement wound dressings were applied according to exudation (strong: calcium alginate, mean: polyurethane foam, low: hydrocolloid). critical bacterial colonization was treated by activated charcoal cloth with sil-ver. criteria for evaluating efficacy were healing time and reduction of ulcer size at the end of observation time.

Eligibility criteria:
inclusion criteria: * therapy resistant wounds for at least 3 months * venous disease * uncle pressure \> 80mmhg * wound area \> 20qcm exclusion criteria: * uncle pressure \<80mmhg

Keywords: healing skin infection wound therapy
effects of pretreatment with different doses of lidocaine on injection pain

Conditions: Rocuronium Adverse Reaction; Lidocaine Adverse Reaction

Summary: one of the medications administered to patients in general anesthesia practice is rocuronium, which causes pain during intravenous administration. it is known that a drug containing lidocaine as the active ingredient can reduce the pain caused by rocuronium in different doses. the effective dose of lidocaine remains a topic of debate. in our study, we aimed to investigate the efficacy of two different doses of lidocaine. no adverse effects are expected from this medication.

the patients were randomly divided into three groups by a simple drawing-lots method: control group (group c), 40 mg lidocaine group (group l) and 1 mg/kg lidocaine group (group l1). all patients were taken to the operating room without premedication and standard monitoring was applied. a 20 g intravenous catheter was inserted on the dorsum of the patients' non-dominant hand, and 100 ml/hour of physiological saline solution was infused over a 5-minute period. after randomization, 5 ml of isotonic solution was administered to the control group, 40 mg of lidocaine to the l group, and 1 mg kg-1 of lidocaine intravenously to the l1 group. patients were administered 0.06 mg/kg of rocuronium, and they were asked, "do you feel any pain or discomfort in your arm?" the pain intensity expressed by the patient was evaluated and recorded using the 5-point pain scale. after induction and intubation, the patients' blood pressure, pulse, and saturation values were recorded.

Eligibility criteria:
inclusion criteria: * all patients aged between 18 and 65 with asa i and ii exclusion criteria: * chronic sedative anxiolytic use * those with asa iii and higher * patients under 18 and over 65 years of age * those with severe copd, asthma, or reactive airway disease * patients with a history of neuropsychiatric or neurological diseases * those with infections on the back of the hand * pregnant women * patients who will undergo rapid induction * patients with liver and kidney dysfunction * those with a history of thrombophlebitis * patients with muscle diseases

Keywords: rocuronium lidocaine
circulating tumor cells and survival in hormone refractory prostate cancer (hrpc) patients receiving chemotherapy

Conditions: Hormone Refractory Prostate Cancer; Prostate Cancer

Summary: this study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen \[psa\] levels) and who were about to start a new line of chemotherapy. blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. the blood was tested to find circulating tumor cells (ctc) and to count them. the circulating tumor cell levels were studied in relation to the patient's overall survival. serum was also collected for psa testing, and additional blood samples were drawn to test for circulating endothelial cells and rna was isolated for future gene expression testing.


Eligibility criteria:
inclusion criteria: * age \> or = 18 years * pathological diagnosis of adenocarcinoma of the prostate * first or later line of chemotherapy * serum testosterone \< 50ng/ml * ecog 0-2 * serum psa \> or = 5ng/ml * psa progression (2 rises above a reference value) * bone scan within 60 days of enrollment * computed tomography (ct) scan * if measurable disease, bone scans every 6-8 months exclusion criteria: * systemic radiation * prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer * brain metastases

Keywords: hormone refractory prostate cancer
healthy volunteer positron emission tomography (pet) brain occupancy study of a phosphodiesterase 4 (pde4) inhibitor in huntington's disease

Conditions: Huntington Disease

Summary: this study will investigate if a new experimental drug to treat huntington's disease gets into the brain. if it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. the study will involve healthy male volunteers.

this is an open label, non-randomized, adaptive design pet occupancy study in healthy adult males. the primary aim of this study is to describe the relationship between plasma concentrations and brain pde4 occupancy of gsk356278 over time. up to 24 healthy volunteers may be administered single doses of gsk356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. this study will help to optimize the dose selection for future clinical studies with gsk356278.

Eligibility criteria:
inclusion criteria: * healthy male volunteer, aged 22-55 years. * normal blood pressure, laboratory values, and body mass index * willing to agree to study procedures \& contraception requirements * capable of giving written informed consent exclusion criteria: * any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse). * previously involved in another clinical trial within 3 months prior to scheduled administration of study drug * smoker * suffers from claustrophobia * any contraindications for mri scanning (e.g. pacemaker, metal implants or fillings)
peripheral nerve stimulation for treatment of sacroiliac joint pain

Conditions: Sacroiliac Joint Pain

Summary: prospective randomized controlled study, primary objective: pain reduction in patients with chronic sacroiliac joint pain after therapy either with peripheral nerve stimulation or with best medical treatment. randomization 4:3 to operative (pns=peripheral nerve stimulation) arm or conservative (bmt= best medical treatment) arm with crossover possibility for the bmt group after 6 months.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years old * subject with chronic sacroiliac joint pain refractory to conservative treatment * subject with nrs of at least 60/100 * subject with temporary pain reduction of at least 50% (nrs) after fluoroscopy guided sij infiltration * subject received conservative treatment for at least three months including physiotherapy and pain medication * subject is able to understand the study and impulse generator programming exclusion criteria: * pregnancy * subject is under age * acute traumatic injury of the isg * active inflammation or neoplastic infiltration of the sij * neoplastic diseases of the spine * spinal surgery within the last three months * the sij pain is not the leading symptom * contraindication for neuromodulation device (severe psychiatric disease, severe coagulation disorder, acute infection, active autoimmune disease with immunosupression)

Keywords: peripheral nerve stimulation back pain sacroiliac joint pain neuromodulation persistent spinal pain syndrome
anterior cruciate ligament reconstruction

Conditions: Ligament Rupture

Summary: this study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.

this is a prospective, comparative, randomized (2-arm), controlled, single-center study of two management modalities. recruitment will focus on adult patients with anterior cruciate ligament rupture and scheduled anterior cruciate ligament surgical reconstruction. patients will be randomized into 2 arms, an experimental arm a (pre-habilitation management) and a control arm b (conventional management).

Eligibility criteria:
inclusion criteria: * age \> 18 ; * partial or complete primary anterior cruciate ligament rupture; * partial or complete primary rupture of the anterior cruciate ligament; * scheduled anterior cruciate ligament reconstructive surgery; * patient with a tablet, computer or smartphone with an internet connection; * patient able to understand and read french; * willingness to complete questionnaires at regular intervals; * membership of a social security scheme; * signed informed consent. exclusion criteria: * recurrence / contralateral lesion ; * stage iii collateral ligament injury;- * osteotomy ; * neurological (motor and/or sensory), vestibular or rheumatic pathology; * pregnant or breast-feeding woman; * protected adult patient (under guardianship, curatorship or deprivation of liberty).
continuous glucose monitoring on patients with active autoimmune diseases following high-dose predisone treatment

Conditions: Glucocorticoid-induced Hyperglycemia

Summary: glucocorticoid is widely used in clinical treatment. recently, there was research about glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active autoimmune diseases. through this prospective trial, the investigators wanted to know the blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or equivalent) in young patients (30-40 years) with active autoimmune diseases with or without low-dose glucocorticoid maintenance. the investigators used continuous glucose monitoring for 72 hours to get a better understanding of the glucose levels.

as known to all, the dosage and duration of glucocorticoid influences the glucose levels in different diseases. continuous glucose monitoring becomes a newly effective technology to better understand the glucose level. in this study,the investigators enrolled 25 patients with certain active autoimmune diseases during high-dosage glucocorticoid therapy at peking union medical college hospital. it was done by monitoring three-day continuous glucose levels by holding continuous glucose monitoring system underneath the skin, which helped to show a unique picture of fluctuations. the participants were divided into two groups according to the glucocorticoid therapy. group 1 enrolled subjects who were newly commenced 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for at least five days. group 2 enrolled subjects who had underwent less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months but treated with high-dose glucocorticoid for the relapse during the study this finding is useful for the suitable treatment to control the hyperglycemia in young patients.

Eligibility criteria:
inclusion criteria: * young patients with exacerbation of autoimmune disease, requiring 1-2mg/kg/day prednisone or equivalent for treatment; * could undergo \<15mg/kg/day prednisone or equivalent glucocorticoid maintenance in the previous three months; exclusion criteria: * patients with history of diabetes; * patients with severe organ dysfunction or failure; * patients with febrile conditions;

Keywords: prednisone, autoimmune disease
clinical performance of histoacryl® lapfix - cannula for laparoscopic inguinal hernia repair

Conditions: Inguinal Hernia

Summary: the goal of this retrospective study is to identify the incidence of hernia recurrence following the application of histoacryl® lapfix - cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. all adult patients who underwent laparoscopic inguinal hernia repair with histoacryl® lapfix - cannula in the period june 2018 - march 2021 at hospital san juan de dios will be analysed. the investigator team will access electronical medical records for the cohort of patients identified.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) * treated between june 2018 and march 2021 at the hospital san juan de dios for laparoscopic mesh fixation with histoacryl lapfix - cannula after inguinal hernia repair surgery. exclusion criteria: * no exclusion criteria has been set.

Keywords: laparoscopic mesh fixation inguinal hernia repair surgery cyanoacrylate histoacryl®
long-term mono-antiplatelet drug strategy after percutaneous coronary intervention

Conditions: Antiplatelet Drug-related Gastrointestinal Injury

Summary: the ocean (long-term mon-antiplatelet drug strategy after percutaneous coronany intervention) study is the largest prospective multicenter data base to investigate the long-term incidence and prognosis of the use of agents for antiplatelet-induced gi injury symptoms (ai-gis) or gi hemorrhage among patients undergoing pci. the ocean study will provide evidence of the long-term incidence and prognosis of use of agents for ai-gis among patients undergoing pci. it has the potential to provide an optimal long-term mono-antiplatelet strategy.

this is a multicenter prospective observational study that will collect data on \>1000 alive patients who have undergone pci between 1 and 1.5 years prior at 9 hospitals from october 2018. adult patients (aged ≥18 years) undergoing pci and prescribed mono-antiplatelet agents (such as aspirin, dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin, and clopidogrel) are eligible for enrollment. in phase 1, patients will be investigated in a cross-sectional manner for the withdrawal rate of dual antiplatelet agents within 1 year after stent implantation. in phase 2, patients will be followed up at 1, 3, and 6 months for ai-gis and other outcomes. the primary endpoint is ai-gis (according to the gastrointestinal symptom rating scale score) or gastrointestinal hemorrhage. secondary outcomes will include bleeding, antiplatelet replacement/discontinuation, health economic cost, utilization ratio of gastrointestinal-protective drugs, and mace.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. currently alive at 1-1.5 years after pci 3. considered by the physician to be suitable for long-term treatment with mono-antiplatelet agents and is currently using a mono-antiplatelet drug (aspirin, clopidogrel, or dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin \[aside\]) 4. provided written informed consent for this study. exclusion criteria: 1. refusal to sign the informed consent form 2. acute coronary syndromes 3. cerebral thrombosis within 1 month or cerebral hemorrhage within 1 year 4. hematopathy or non-gi bleeding tendency 5. allergy to aspirin 6. severe uncontrolled hypertension (\>180/110 mmhg) 7. pregnancy or lactation 8. drug or alcohol abuse 9. malignant tumor or \<1-year life expectancy

Keywords: coronary heart disease mono-antiplatelet drug antiplatelet-induced gastrointestinal injury symptom medication adherence prospective observational study